MAUDE Adverse Event Report: CARDIA INNOVATION CARBONAID CO2 DIFFUSER

Catalog Number 2905

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During an open-heart valve replacement procedure, the carbonaid co2 diffuser was going to be used.Prior to opening the heart, it was discovered that the sponge on the sponge-tipped hose end was no longer attached to the device.No effect on pt.The surgeon wanted onxlti to know that this occurred as the foam tip could have been lost during the case.

• Brand Name: CARBONAID CO2 DIFFUSER
• Type of Device: CO2 DIFFUSER
• Manufacturer (Section D): CARDIA INNOVATION; stockholm ; SW
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 8200 cameron rd., a-196; austin TX 78754
• Manufacturer Contact: 8200 cameron rd., a-196; austin, TX 78754
• MDR Report Key: 4741817
• MDR Text Key: 5769288
• Report Number: 1649833-2015-00006
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2016
• Device Catalogue Number: 2905
• Device Lot Number: 125502
• Other Device ID Number: NONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2015
• Distributor Facility Aware Date: 04/14/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other